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The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study

Information source: University of Utah
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Irritable Bowel Syndrome

Intervention: Mesalamine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University of Utah

Official(s) and/or principal investigator(s):
Ashok Tuteja, Principal Investigator, Affiliation: Gastroenterology

Overall contact:
Deva P Gundupalli, MS,MPH, Phone: 801-581-8051, Email: dev.gundupalli@utah.edu

Summary

The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma cytokines before and after treatment with Lialda. This study will test long acting mesalamine in the management of PI-IBS. It has the potential to improve QOL and perhaps gastrointestinal symptoms, in patients with PI-IBS. The results of this study, if positive, will provide preliminary data for a large scale clinical trial. This study will also provide information about plasma cytokines in patients with PI-IBS and whether improvement in symptoms correlates with improvement in plasma cytokines.

Clinical Details

Official title: The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change from baseline in gastrointestinal symptoms and IBS specific quality of life after an 8 week treatment period

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: Inclusion Criteria 1. Men and women age 18-75 years 2. Rome III criteria for IBS 3. Symptom onset after apparent acute gastroenteritis 4. Symptoms of 6 months or greater duration 5. Normal gross appearance of the colonic mucosa other than erythema 6. Negative markers for celiac disease and inflammatory bowel disease 7. Normal thyroid function and serum calcium 8. Stable medication regimens for other medical conditions. Exclusion Criteria: 1. Age <18 or >75 years 2. Previous diagnosis of or history compatible with IBS 3. Constipation-predominant IBS. 4. Clinically significant chronic cardiac, pulmonary, hepatic, renal dysfunction or HIV 5. History of/or presence of malignancy 6. Current evidence of any gastrointestinal disorder such as celiac disease, inflammatory bowel disease, chronic pancreatitis, scleroderma, HIV, small bowel or colonic resection, paraplegia or quadriplegia. . 7. Current evidence of drug or alcohol abuse as judged by the investigator 8. Allergy to mesalamine or aspirin 9. Investigator perception of patient's inability to comply with the study protocol 10. Unstable psychiatric disease 11. Recent change in gastrointestinal medications

Locations and Contacts

Deva P Gundupalli, MS,MPH, Phone: 801-581-8051, Email: dev.gundupalli@utah.edu

University of Utah, Salt Lake City, Utah 84132, United States; Recruiting
Deva P Gundupalli, MS,MPH, Phone: 801-581-8051, Email: dev.gundupalli@utah.edu
Ashok Tuteja, M.D., Principal Investigator
Additional Information

Starting date: June 2010
Last updated: May 15, 2014

Page last updated: November 27, 2014

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